Bur, Surgical, General & Plastic Surgery
FDA product code GFF · Class I (low risk) · 21 CFR 878.4820 · General, Plastic Surgery
16510(k) clearances
0PMA approvals
12recalls
Manufacturers
- Micro-Aire Surgical Instruments, Inc. 4
- Spire Medical, Inc. 1
- Techmedica, Inc. 1
- Acumed Instruments Corp. 1
- Tava Surgical Instruments 1
- Nuell Air Equipment & Hospital Supplies, Inc. 1
- New England Surgical Instrument Corp. 1
- Komet Medical, Div. of Brasseler USA I, L.P. 1
- Danek Medical, Inc. 1
- American Medical Specialties, Inc. 1
- Komet Medical 1
- Transidyne General Corp. 1
- The Anspach Effort, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974025 | Anspach Shielded AttachmentGFF · Traditional | The Anspach Effort, Inc. | 07/06/1998SE |
| K950449 | Surgical BurGFF · Traditional | Transidyne General Corp. | 03/01/1995SE |
| K943758 | Surgical BurGFF · Traditional | Komet Medical | 08/22/1994SE |
| K934583 | BurrsGFF · Traditional | American Medical Specialties, Inc. | 01/26/1994SE |
| K894438 | Micro-Aire Cutters for Midas-Rex InstrumentsGFF · Traditional | Micro-Aire Surgical Instruments, Inc. | 08/21/1989SE |
| K890090 | Danek Irrigating Burr (Dib) SetGFF · Traditional | Danek Medical, Inc. | 01/24/1989SE |
| K883255 | Komet Surgical BurGFF · Traditional | Komet Medical, Div. of Brasseler USA I, L.P. | 09/15/1988SE |
| K880859 | Surgical BursGFF · Traditional | New England Surgical Instrument Corp. | 03/21/1988SE |
| K880706 | Surgical BursGFF · Traditional | Nuell Air Equipment & Hospital Supplies, Inc. | 02/26/1988SE |
| K872475 | Surgical BurGFF · Traditional | Tava Surgical Instruments | 07/02/1987SE |
| K862852 | Micro-Aire Replace Otology Burs/Zim Hall Sur InstrGFF · Traditional | Micro-Aire Surgical Instruments, Inc. | 08/11/1986SE |
| K853658 | Burs for Micro Surgical Drill SystemGFF · Traditional | Acumed Instruments Corp. | 09/24/1985SE |
| K850497 | Micro-Aire Generic Burs & DrillsGFF · Traditional | Micro-Aire Surgical Instruments, Inc. | 03/01/1985SE |
| K841298 | Hole Chamfering DeviceGFF · Traditional | Techmedica, Inc. | 04/25/1984SE |
| K821485 | DermabradersGFF · Traditional | Spire Medical, Inc. | 06/10/1982SE |
| K820281 | Micro-Aire Replacement Drill BursGFF · Traditional | Micro-Aire Surgical Instruments, Inc. | 02/23/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1283-2021 Class II | In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive…This Field Action is being conducted following identification of manufacturing non-conformity of some… | In2Bones, SAS | 02/09/2021Terminated |
| Z-0591-2020 Class II | BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm…One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device. | Brasseler USA I Lp | 10/18/2019Terminated |
| Z-1206-2019 Class II | Arthrex Burr, Oval, 12 Flute, 5.5 mm x 13 cm (AR-8550OBT) These devices are indicated…Devices may generate excessive heat during use. | Arthrex, Inc. | 01/14/2019Terminated |
| Z-0568-2020 Class II | Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514The firm discovered a lack of adequate documentation confirming sterility on certain products. | Wright Medical Technology, Inc. | 11/08/2016Terminated |
| Z-1940-2017 Class II | 19cm Attachment, Black Max Product Usage: Pneumatic systemSupplied Directions for Use (DFU) did not contain a recommended service interval. | The Anspach Effort, Inc. | 10/06/2016Terminated |
| Z-1842-2016 Class II | Hip Preservation System Signature Series PreBent Burs under the following labels: 1)…Metal shavings released from burs during use are due to contact between the bur and the hood of the PreBent… | ConMed Corporation | 12/21/2015Terminated |
| Z-2247-2015 Class II | Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A; Pouch…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | EXP Pharmaceutical Services Corp | 02/11/2015Terminated |
| Z-1631-2013 Class II | - Acorn Bur, Long, For Use With TPS Universal Drill, Long "AM" Attachment Head: 7.5mm…The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point… | Surgical Instrument Service And Savings, Inc. | 05/03/2013Terminated |
| Z-0632-2014 Class II | Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting…Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where… | The Anspach Effort, Inc. | 06/11/2012Terminated |
| Z-0830-2014 Class II | Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile…Cutter was longer than was stated on the label | The Anspach Effort, Inc. | 03/31/2011Terminated |
| Z-0550-2009 | Burrs Model #'s: ANSL-3SB ANSL-5D ANSQD11-4OVDC HAL5056-118 HAL5056-166 HAL5091-106…SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed… | Sterilmed Inc | 08/08/2008Terminated |
| Z-0711-2008 | ConMed Linvatec, Ultrapower Burs, Linvatec Corporation, Largo, FL 33773Compromised sterility: ConMed Linvatec medical devices packaged within a certain Peel Pouch Sterile Package… | Linvatec Corp. | 08/09/2007Terminated |